AstraZeneca PLC (LSE:AZN) said an advanced-stage study of its Imfinzi drug failed to meets its target of improving survival in patients with cervical cancer.
The CALLA phase 3 trial of Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoint to improve progression-free survival in patients with locally advanced cervical cancer when used concurrently with chemoradiotherapy (CRT), compared with the use of CRT alone, the pharmaceutical firm said in a statement.
It pointed out that the safety and tolerability in the trial were consistent and no new unexpected safety findings were observed during the trial.
“While the results were not what we hoped for, insights from the trial will advance our understanding and application of immunotherapy across our broad clinical development programme, exploring the benefits of Imfinzi in many tumour types,” said Susan Galbraith, AstraZeneca’s executive vice president for oncology R&D.
The trial tested 770 patients with locally advanced cervical cancer with standard CRT care in combination with either a 1,500mg fixed dose of Imfinzi or placebo every four weeks for up to 24 cycles or until disease progression.
The company is pursuing a comprehensive clinical trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.